6-year Follow-up of Dysphagia in Patients With Parkinson's Disease

We recruited 116 patients with idiopathic PD who were from the Neurology clinic of the Second Affiliated Hospital of Zhejiang University, School of Medicine from January 2014 to November 2014. Perform videofluroscopic swallowing study and psychiatric and neurological evaluations and followed up after 6 years.

Study Overview

• Status: Enrolling by invitation
• Conditions: Parkinson Disease; Dysphagia
• Intervention / Treatment: Procedure: deep brain stimulation; Drug: Anti-Parkinsonian Drugs

Detailed Description

In baseline, 116 patients with idiopathic PD were recruited from the Neurology Clinic of the Second Affiliated Hospital of Zhejiang University School of Medicine according to the United Kingdom PD Society Brain Bank Clinical Diagnostic Criteria. They were admitted from January 2014 to November 2014, and were followed up after 6 years.

Perform psychiatric and neurological evaluations. And use Videofluoroscopic swallowing study (VFSS) to assess the swallowing function of PD patients. Added 200mg of barium sulfate to 286ml water to achieve a concentration of 60%. Add a thickener (Ourdiet Swallow, Ourdiet Biotech Co. Ltd, Guangzhou, China) to prepare juice and pudding viscosities, No thickener was added to the liquid viscosity. The patients were advised to have boluses of 3, 5 and 10 ml of the liquid, juice, pudding viscosities in sequence according to the clinician's instructions under X-ray fluoroscopy. The patients ware sitting or standing, The lateral view of the patients' swallow was recorded by a camera (30 frames per second). The radiologist, the clinician, and the rehabilitation therapist completed this examination. Two person analyzed the video in slow motion and frame - by - frame, and record abnormal results. The VFSS inspection parameters are Penetration/aspiration score and Residue score. In order to reduce the influence of drugs on dysphagia, all patients were in the off - period. The patients stopped taking anti-Parkinson's disease drugs from 9 o'clock the night before the examination, and were tested in the morning (free of medicine for more than 12 hours).

The patients had completed the above tests in 2014 and were asked to perform the above assessments again.

• Study Type: Observational
• Enrollment (Actual): 116

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

116 idiopathic PD

Description

Inclusion Criteria:

• idiopathic PD according to the United Kingdom PD Society Brain Bank Clinical Diagnostic Criteria.

Exclusion Criteria:

• (1) Parkinsonian syndromes;(2) with severe lung disease, severe liver insufficiency and cardiac insufficiency; (3) Kubota water drinking test grade ≥3; (4) have had or combined other diseases that affect swallowing function; (5) Nasal feeding, gastric reflux or gastrostomy; (6) Mental disorders Or patients with low intelligence and cognitive function, unable to understand and cooperate with the examination.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
penetration - aspiration score	according to the 8-Point Penetration-Aspiration Scale, PAS ≥ 6 means that material enters below the vocal cords.	in the morning, before taking anti-parkinson drugs
residue score	evaluate the residue in the oral cavity and pharynx (vallecula, pyriform sinuses) after the first swallowing. Residue amount was rated on a scale from 0 to 3: no residue visible, 0 score; mild residue (less than 25% of the level of the height of the structure), 1 score; moderate residue (25% to 50% of the height of the structure), 2 score; severe residue (high than 50% of the structure height), 3 score.	in the morning, before taking anti-parkinson drugs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
water swallow test	The patient is asked to sit in a chair, and is handed a cup containing 30 mL of water at normal temperature. The patient is then asked to "Please drink this water as you usually do." Time to empty a cup is measured, and the drinking profile and episodes are monitored and assessed.	in the morning, before taking anti-parkinson drugs
SDQ-C	The Chinese version of the Swallowing Disturbance Questionnaire	in the morning, before taking anti-parkinson drugs

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
MMSE	Mini-mental State Examination (MMSE)；	in the morning, before taking anti-parkinson drugs
HAMD	Hamilton Depression Scale	in the morning, before taking anti-parkinson drugs
HAMA	Hamilton Anxiety Scale	in the morning, before taking anti-parkinson drugs
H&Y	Hoehn-Yahr stage	in the morning, before taking anti-parkinson drugs
PDQ-39	Parkinson Disease Quality of Life Measure	in the morning, before taking anti-parkinson drugs
NMSQ	Non-Motor Symptoms Quest	in the morning, before taking anti-parkinson drugs

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Wei Luo, PhD, the Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China

Publications and helpful links

General Publications

• Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. Dysphagia. 1996 Spring;11(2):93-8. doi: 10.1007/BF00417897.
• Argolo N, Sampaio M, Pinho P, Melo A, Nóbrega AC. Videofluoroscopic Predictors of Penetration-Aspiration in Parkinson's Disease Patients. Dysphagia. 2015 Dec;30(6):751-8. doi: 10.1007/s00455-015-9653-y. Epub 2015 Oct 22.
• Fukuoka T, Ono T, Hori K, Wada Y, Uchiyama Y, Kasama S, Yoshikawa H, Domen K. Tongue Pressure Measurement and Videofluoroscopic Study of Swallowing in Patients with Parkinson's Disease. Dysphagia. 2019 Feb;34(1):80-88. doi: 10.1007/s00455-018-9916-5. Epub 2018 Jun 8.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Anticipated): July 31, 2021
• Study Completion (Anticipated): July 31, 2021

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 16, 2021

Study Record Updates

• Last Update Posted (Actual): June 16, 2021
• Last Update Submitted That Met QC Criteria: June 9, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Parkinson's Disease; dysphagia
• Additional Relevant MeSH Terms: Digestive System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Esophageal Diseases; Parkinson Disease; Deglutition Disorders; Anti-Dyskinesia Agents; Antiparkinson Agents
• Other Study ID Numbers: （2020）LunShenYan（ 191 ）

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No